510(k) K231461

Smart Correction System (HA Half Pins) by Wishbone Medical, Inc. — Product Code KTT

K231461 is an FDA 510(k) premarket notification submitted by Wishbone Medical, Inc. for the device "Smart Correction System (HA Half Pins)". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Wishbone Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
May 19, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type